NCT04020497

Brief Summary

This study focuses on the difficulties of maintaining optimal psychological health and quality of life for caregivers in adult psychiatry while they play an important role in helping patients with severe psychiatric disorders. It evaluates the addition of a 5 session psychological program, named Ensemble. Half of the participants will receive their usual support and Ensemble in combination, while the other half will receive usual support only.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

July 12, 2019

Last Update Submit

August 16, 2021

Conditions

Psychological Distress

Keywords

target supportinformal caregiverrecoverywell-beingburdenquality of life

Outcome Measures

Primary Outcomes (1)

  • Psychological state change on the Global Severity Index (GSI)

    Assessment of psychological symptoms and psychological distress (BSI scale). The Brief Symptom Inventory (BSI) includes 53 items organized into 9 primary and clinically relevant symptom dimensions: 1) somatization, 2) obsessive-compulsive, 3) interpersonal sensitivity, 4) depression, 5) anxiety, 6) hostility, 7) phobic anxiety, 8) paranoid ideation and 9) psychoticism. This scale has also three global distress indices: The Global Severity Index (GSI), the Positive Symptom Distress Index (PSDI) and the Positive Symptom Total (PST).

    Change from Baseline composite on the GSI score at post-test, and at 2 months follow

Secondary Outcomes (4)

  • Optimism change on the Life Orientation Test-Revised (LOT-R)

    Change from Baseline total score of the LOT-R at post-test, and at 2 months follow

  • Quality of life change on the Mental Component Score (MCS)

    Change from Baseline composite on the MCS score at post-test, and at 2 months follow

  • Burden level change on the Zarit Burden Intervieuw (ZBI)

    Change from Baseline on the Zarit score at post-test and at 2 months follow

  • Standardized severity of the patient's illness change on the Social an Occupational Functioning Assessment Scale (SOFAS)

    Change from Baseline on the SOFAS score at 2 months follow

Study Arms (2)

Ensemble + SAU (Support as usual)

EXPERIMENTAL

The five-session Ensemble program provided to informal caregivers targeted support + SAU

Behavioral: Ensemble programmeOther: SAU

SAU (Support as usual)

ACTIVE COMPARATOR

SAU alone which was chosen as a control condition.

Other: SAU

Interventions

Ensemble programmeBEHAVIORAL

Ensemble is a individualized programme to address informal caregiver's specific unmet needs, emotions and social resources, in order to offer a targeted support in five sessions.

Also known as: Ensemble
Ensemble + SAU (Support as usual)
SAUOTHER

Informal caregivers have often to manage the situation in usual different ways. Support as usual (SAU) alone consists of an informal support by patient's clinical team. Specific psychoeducational programs depending on patient's illnes (like "Profamille" for schizophrenia) or peer-support depending to the voluntary work of families' associations. Some general professional services focused on informal caregivers or relatives in order to inform and orient them if they are avaible in the study area. No attempts have been made to standardize this treatement as SAU depend to informal caregiver's need and knowledge of the health system, also her/his capacity or possibility to be in contact with patient's clinical team.

Also known as: Support as usual
Ensemble + SAU (Support as usual)SAU (Support as usual)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being at least 18 years old
  • Living in the French-speaking cantons of Switzerland (commonly referred to as "Romandy")
  • Speaking French
  • Having an adult relative suffering from a psychiatric disorder (with or without an established diagnosis)
  • Having the capacity to agree to participate in the project

You may not qualify if:

  • \- Having les than 20 on the Zarit score.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Source, School of Nursing Sciences, HES-SO University of Applied Sciences Western Switzerland, Lausanne.

Lausanne, Canton of Vaud, 1004, Switzerland

Location

Related Publications (4)

  • Rexhaj S, Leclerc C, Bonsack C, Favrod J. Approche pour cibler le soutien auprès des proches aidants de personnes souffrant de troubles psychiatriques sévères. Annales Médico-psychologiques, revue psychiatrique 75 (9): 781-788. 2017.

    BACKGROUND

  • Rexhaj S, Monteiro S, Golay P, Coloni-Terrapon C, Wenger D, Favrod J. Ensemble programme for early intervention in informal caregivers of psychiatric adult patients: a protocol for a randomised controlled trial. BMJ Open. 2020 Jul 30;10(7):e038781. doi: 10.1136/bmjopen-2020-038781.

    PMID: 32737097BACKGROUND

  • Rexhaj S, Leclerc C, Bonsack C, Golay P, Favrod J. Feasibility and Accessibility of a Tailored Intervention for Informal Caregivers of People with Severe Psychiatric Disorders: a Pilot Study. Front Psychiatry. 2017 Sep 21;8:178. doi: 10.3389/fpsyt.2017.00178. eCollection 2017.

    PMID: 28983262RESULT

  • Rexhaj S, Martinez D, Golay P, Coloni-Terrapon C, Monteiro S, Buisson L, Drainville AL, Bonsack C, Ismailaj A, Nguyen A, Favrod J. A randomized controlled trial of a targeted support program for informal caregivers in adult psychiatry. Front Psychiatry. 2023 Nov 30;14:1284096. doi: 10.3389/fpsyt.2023.1284096. eCollection 2023.

    PMID: 38098635DERIVED

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Shyhrete Rexhaj

    Institut et Haute école de la Santé, La Source

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Porfessor associate HES

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 16, 2019

Study Start

September 1, 2019

Primary Completion

January 1, 2021

Study Completion

April 30, 2023

Last Updated

August 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)